Title: Associate Director, Clinical Development Trial Lead (CDTL)
Pay Rate: $104/ HR.
Location: Remote
Job Description: We are seeking an experienced Clinical Development Trial Lead (CDTL) with a strong background in Oncology Clinical Development to lead complex global clinical trials. The ideal candidate will have recent hands-on experience managing early-phase oncology studies, including Phase 1 trials with dose-escalation and dose-expansion cohorts, and a proven track record of delivering clinical studies in a global environment.
Must have:
The hiring manager is placing significant emphasis on Phase I Oncology experience, particularly complex global studies involving dose-escalation and expansion cohorts.
8+ years of Phase I clinical trial experience
8+ years of Oncology experience
8+ years of Clinical Operations experience
Leading complex global Phase I oncology studies
Dose-escalation and dose-expansion cohort management
End-to-end study ownership (Start-up through Closeout)
Working in a Sponsor + CRO hybrid model
Vendor oversight and management
TMF ownership and inspection readiness
Budget, enrollment, timeline, and risk management
Key Requirements
- Strong and current Oncology clinical trial experience
- Extensive experience leading Phase 1 / Early-Phase Oncology Studies
- Experience managing:
- Dose-Escalation Cohorts
- Dose-Expansion Cohorts
- First-in-Human (FIH) studies preferred
- End-to-end Clinical Operations leadership from study startup through closeout
- Experience leading complex global, multi-country clinical trials
- Strong Sponsor/CRO hybrid model experience
- Proven CRO and vendor management expertise
- Ability to lead and influence cross-functional global teams
- Strong understanding of GCP, clinical trial regulations, and clinical development processes
- Excellent project management, risk management, and problem-solving skills
Preferred Background
- Clinical Development Trial Lead (CDTL)
- Associate Director, Clinical Operations
- Global Trial Manager
- Clinical Study Lead
- Clinical Program Lead
- Senior Clinical Trial Manager
- Clinical Operations Lead
Preferred Skills
- Early-Phase Oncology Development
- Global Clinical Trial Management
- Clinical Operations Leadership
- CRO Oversight & Vendor Management
- Trial Master File (TMF)
- Veeva
- MS Project
- Power BI
- Enrollment Strategy & Trial Execution
Qualifications
- Bachelor's degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or a related scientific discipline
- 8+ years of clinical research experience required
- Significant experience leading global oncology clinical trials strongly preferred
Ideal Candidate - This position is best suited for professionals currently leading or recently involved in global Phase 1 oncology studies, with deep expertise in dose-escalation and dose-expansion trial designs, strong clinical operations leadership, and demonstrated success managing CROs, vendors, and cross-functional global teams.
Featured benefits
Medical insurance, Vision insurance, Dental insurance
Requirements added by the job poster
• 8+ years of work experience with Clinical Operations
• 8+ years of work experience with Oncology
• 8+ years of work experience with Clinical Research
